Senior researcher Pharmaceutical Care
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Study on off-label use of medicinal products in the European Union.
Weda, M., Hoebert, J., Vervloet, M., Moltó Puigmarti, C., Damen, N., Marchange, S., Langedijk, J., Lisman, J., Dijk, L. van. Study on off-label use of medicinal products in the European Union. Utrecht/Bilthoven: NIVEL, epha, RIVM, 2017. 193 p.
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This report describes the results of the study on the complex field of off-label use; the terms under which a product can be used safely and effectively are described in the product information. The study covers the public health aspects related to the off-label use of medicinal products, and in particular the balance between its benefits and risks for patients, and the regulatory framework for the off-label use of medicines.
The general objective of the study is to provide a description of existing and foreseen practices of off-label use across Member States and a factual analysis of all parties’ positions towards the existing measures and possible envisaged tools to regulate the off-label medicine use at national level.
The general objective of the study is to provide a description of existing and foreseen practices of off-label use across Member States and a factual analysis of all parties’ positions towards the existing measures and possible envisaged tools to regulate the off-label medicine use at national level.
This report describes the results of the study on the complex field of off-label use; the terms under which a product can be used safely and effectively are described in the product information. The study covers the public health aspects related to the off-label use of medicinal products, and in particular the balance between its benefits and risks for patients, and the regulatory framework for the off-label use of medicines.
The general objective of the study is to provide a description of existing and foreseen practices of off-label use across Member States and a factual analysis of all parties’ positions towards the existing measures and possible envisaged tools to regulate the off-label medicine use at national level.
The general objective of the study is to provide a description of existing and foreseen practices of off-label use across Member States and a factual analysis of all parties’ positions towards the existing measures and possible envisaged tools to regulate the off-label medicine use at national level.
